NIH Required Ethics Education

Starting October 1, 2000, all investigators submitting to NIH will be required to complete an education program on the protection of human research subjects and to include a description of such education in the application (see NIH Guide at NOT-0D-00-039). Currently, because of NIH "Just-in-time" procedures for the use of human subjects in research, this will only effect investigators submitting their non- competing renewal applications (progress reports). These progress reports must include this description.

To assist investigators in their applications, ORPA has prepared appropriate language, one for research that involves greater than minimal risk and another for research that is minimal risk. The education requirement for minimal risk investigators is also new to the University and will be further addressed by the Research Subjects Review Board Office. Investigators with collaborative relationships with other institutions (subcontracts) will be responsible for ensuring that their progress reports contain a similar statement from the subcontractor(s).

In addition, ORPA has written letters of certification to be provided to NIH "Just-in-time," when funding of the new proposal seems likely. NIH had announced that the letter documenting completion of the education required signatures of both the official authorized to represent the applicant institution and the principal investigator. In an effort to streamline the submission of the required documentation, NIH staff will accept a letter signed by the Institutional Authorizing Official (your Research Administrator). It is not required that the principal investigator also sign the letter. The letter will certify that all key personnel involved in the design and conduct of the research study involving the use of human subjects have completed the education requirement. For those PI's collaborating with investigators at other institutions via subcontracts, the letter can be shown as a sample of what must be provided "just-in-time" to the University of Rochester.

NIH has put out on its website FAQ's (frequently asked questions) about this issue. They can be accessed at NIH FAQ